青少年注意缺陷多动障碍的微量营养素：一项安慰剂对照随机临床试验。
Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial.
机构信息
Oregon Health & Science University, Portland; National University of Natural Medicine, Helfgott Research Institute, Portland, Oregon.
The Ohio State University, Columbus.
出版信息
J Am Acad Child Adolesc Psychiatry. 2022 May;61(5):647-661. doi: 10.1016/j.jaac.2021.07.005. Epub 2021 Jul 22.
OBJECTIVE
To evaluate whether micronutrients (vitamins/minerals) benefit attention-deficit/hyperactivity disorder (ADHD) and irritability in a North American pediatric sample.
METHOD
A 3-site, 8-week, placebo-controlled, randomized clinical trial of micronutrients was conducted in nonmedicated children aged 6 to 12 years with ADHD and at least 1 impairing irritability symptom by parent report on the Child and Adolescent Symptom Inventory-5 (CASI-5). A priori-defined primary outcomes were Clinical Global Impression-Improvement (CGI-I) (CGI-I of 1 or 2 = treatment responder) and parent-rated CASI-5 composite score of ADHD, oppositional defiant, disruptive mood dysregulation, and peer conflict symptoms, including impairment scores.
RESULTS
Of 135 randomized (mean age 9.8 years), 126 youths (93%) comprised the modified intention-to-treat population. Blinding was maintained. For the CGI-I, 54% of the micronutrient and 18% of the placebo group were responders (risk ratio = 2.97, 97.5% CI = 1.50, 5.90, p < .001). CASI-5 composite scores improved significantly for both groups (p < .01), with a mean change of -0.31 (95% CI = -0.39, -0.23) in the micronutrient group and a mean change of -0.28 (95% CI = -0.38, -0.19) in the placebo group. However, the between-group difference was not significant (mean change = -0.02; 97.5% CI = -0.16, 0.12, effect size = 0.07, p = .70). The micronutrient group grew 6 mm more than the placebo group (p = .002). No serious adverse events or clinically significant changes from baseline in blood and urine tests occurred.
CONCLUSION
Micronutrients showed global benefit over placebo by blinded clinician rating, but not by parent-report CASI-5 composite rating in a population with ADHD and irritability. Micronutrients showed greater height growth. Micronutrients were well tolerated, and the majority of participants adhered to the number of capsules prescribed. This randomized controlled trial replicates safety and efficacy reported for ADHD in 2 smaller trials of a similar formula containing all vitamins and known essential minerals in amounts between the Recommended Dietary Allowance and Upper Tolerable Intake Level.
CLINICAL TRIAL REGISTRATION INFORMATION
Micronutrients for ADHD in Youth (MADDY) Study; https://clinicaltrials.gov; NCT03252522.
目的
评估在北美儿科样本中，微量营养素（维生素/矿物质）是否有益于注意缺陷/多动障碍（ADHD）和易激惹。
方法
对 135 名随机分组（平均年龄 9.8 岁）的儿童进行了为期 8 周的 3 个地点、安慰剂对照、随机临床试验，这些儿童均为非药物治疗的 6 至 12 岁 ADHD 儿童，且至少有 1 项父母报告的儿童青少年症状量表 5 项（CASI-5）的激惹症状损害。预先定义的主要结局为临床总体印象改善（CGI-I）（CGI-I 为 1 或 2=治疗反应者）和父母评定的 ADHD、对立违抗性、破坏性情绪失调、同伴冲突症状的 CASI-5 综合评分，包括损害评分。
结果
126 名（93%）接受改良意向治疗的青少年（平均年龄 9.8 岁）构成了改良意向治疗人群。保持了盲法。对于 CGI-I，微量营养素组有 54%的儿童和安慰剂组有 18%的儿童为反应者（风险比=2.97，97.5%CI=1.50，5.90，p<0.001）。两组的 CASI-5 综合评分均显著改善（p<0.01），微量营养素组平均变化为-0.31（95%CI=-0.39，-0.23），安慰剂组平均变化为-0.28（95%CI=-0.38，-0.19）。然而，组间差异无统计学意义（平均变化=-0.02；97.5%CI=-0.16，0.12，效应量=0.07，p=0.70）。微量营养素组比安慰剂组身高增长了 6 毫米（p=0.002）。未发生任何严重不良事件，也未出现血液和尿液检测的临床显著变化。
结论
在 ADHD 和易激惹的人群中，微量营养素通过盲法临床医生评估显示出优于安慰剂的整体获益，但通过父母报告的 ADHD 的 CASI-5 综合评分则没有显示出差异。微量营养素显示出更大的身高增长。微量营养素耐受性良好，大多数参与者都按照规定的胶囊数量服用。这项随机对照试验复制了在 2 项类似配方的 ADHD 较小试验中报告的安全性和疗效，这些配方含有所有维生素和已知的必需矿物质，其含量在推荐膳食摄入量和可耐受最高摄入量之间。
临床试验注册信息
儿童注意缺陷多动障碍的微量营养素（MADDY 研究）；https://clinicaltrials.gov；NCT03252522。
Zotero 插件